FDA issues warning over painkiller
28 September, 2007
The United States Food and Drug
Administration (FDA) has warned the
public about the potential fatal risk
associated with the improper use of
painkiller drug Fentora, manufactured
by Cephalon Incorporated.
The warning comes after Cephalon, the
biopharmaceutical company based in the
United States, warned doctors earlier
in September 2007 about several
patient deaths related to
inappropriate prescribing of Fentora.
In its letter to health professionals
on September 10, 2007, Cephalon said
patient deaths were on account of
improper patient selection, dosing, or
product substitution. It also warned
that Fentora should not be used as a
replacement for a similar painkiller
sold by Cephalon called Actiq.
Fentora delivers more medication to
the blood than Actiq, and substituting
the same dose for Actiq can be fatal,
the FDA said.
Fentora is made from fentanyl, which
in raw form is 80 times stronger than
morphine. Cephalon officials said
that, once fentanyl is processed, the
difference is much less.
Fentora is approved only for treating
pain in cancer patients who experience
‘breakthrough pain’ because they have
developed tolerances to other opiate
painkillers, such as morphine.
Breakthrough cancer pain is an intense
increase in pain that occurs in
bursts, with rapid onset even when
pain-control medication is being used.
In its advisory, the FDA has cautioned
against people taking Fentora for
migraines or other types of short-term
Doctors can prescribe drugs for uses
outside their approved labeling, a
practice known as “off-label use.”
Many doctors prescribe Fentora
off-label for headaches and back pain.
Once a drug has been approved by the
FDA, doctors are free to prescribe it
as they deem fit.
The FDA said several Fentora-related
deaths have occurred in patients who
were prescribed the drug for off-label
It warned that Fentora should not be
used for any other conditions. It
should only be given to patients who
have developed opiate tolerance, as
others will not be able to handle the
high amounts of fentanyl contained in
The FDA also warned people taking
Fentora and their caregivers to follow
carefully the drug’s label directions.
The agency advised that patients and
caregivers become familiar with the
signs of fentanyl overdose.
Cephalon Incorporated is now working
with the FDA to update Fentora’s
package insert to include revised
patient selection criteria and dosing
The company has been testing the use
of Fentora for other types of pain,
and had announced in August 2007 that
it expected to seek FDA approval for
expanding the approved uses for the
drug by the end of 2007.
In 2006, an inquiry by the
attorney-general of Connecticut had
found that Cephalon promoted some
drugs for uses for which they were not
approved, a practice that is illegal.
Dr Scott Fishman, former president of
the American Academy of Pain Medicine
and professor at the University of
California in Davis, said a big issue
is that doctors are not trained in
pain management, especially with
faster-acting painkillers like Actiq